Dyspnea-induced Limitation (DYSLIM), a new self-administered concise questionnaire to evaluate dyspnea-related activity limitation in chronic respiratory diseases.

BACKGROUND AND AIM: Few questionnaires are available for routine assessment of dyspnea. The study aimed to design a self-administered questionnaire assessing the impact of chronic dyspnea on daily activities, named DYSLIM (Dyspnea-induced Limitation). METHODS: The development followed 4 steps: 1: selection of relevant activities and related questions (focus groups); 2: clinical study: internal and concurrent validity vs. modified Medical Research Council (mMRC), Baseline Dyspnea Index (BDI) and Saint George Respiratory Questionnaire (SGRQ); 3: item reduction; 4: responsiveness. Eighteen activities (from eating to climbing stairs) were considered with 5 modalities for each: doing the task slowly, taking breaks, seeking assistance, changing habits, and activity avoidance. Each modality was graded from 5 (never) to 1 (very often). Validation study included 194 patients: COPD (FEV1 ≥ 50% pred: n = 40; FEV1 < 50% pred: n = 65); cystic fibrosis (n = 30), interstitial lung disease (n = 30), pulmonary hypertension (n = 29). Responsiveness was evaluated by post-pulmonary rehabilitation data in 52 COPD patients. RESULTS: Acceptability was high and short term (7 days) reproducibility was satisfactory (Kappa mostly above 0.7). Concurrent validity was high vs. mMRC (Spearman correlation coefficient, r = 0.71), BDI (r = - 0.75) and SGRQ (r = - 0.79). The reduced questionnaire with 8 activities (from cleaning to climbing stairs) and 3 modalities (slowly, seeking help, changing habits) showed a comparable validity and was chosen as the final short version. Effect size of rehabilitation was good for both the full (0.57) and short (0.51) versions. A significant correlation was also found between changes of SGRQ and DYSLIM post rehabilitation: r = - 0.68 and r = - 0.60 for full and reduced questionnaires, respectively. CONCLUSION: The DYSLIM questionnaire appears promising for the evaluation of dyspnea-induced limitations in chronic respiratory diseases and seems suitable for use in various contexts.

Clustering of COPD patients and their response to pulmonary rehabilitation.

BACKGROUND AND OBJECTIVE: Pulmonary rehabilitation (PR) is fundamental in the management of chronic obstructive pulmonary disease (COPD). COPD patients show a large clinical heterogeneity that may influence their response to PR. Identification of homogeneous clusters of patients who may or may not respond to PR is important to personalize patient care. This study aimed at identifying distinct clinical phenotypes of COPD patients and assessing their respective 6-min walking distance (6MWD) response to in-patient PR. METHODS: This is a cohort-based analysis of COPD patients admitted to a PR center between January 2012 and December 2017. Pre-PR patients' characteristics, lung function and 6-min walking test parameters were introduced in a hierarchical ascending clustering approach to identify distinct clusters. RESULTS: Out of 835 patients, 4 distinctive clusters were identified. The most likely to show clinically significant 6MWD improvement post-PR (responders) were cluster 1 (younger men, GOLD I-II, average walkers, obese; non-response rate: 16%), cluster 2 (older women, GOLD II-III, slow walkers; 18%), and cluster 3 (older men, GOLD II-III, dyspneic, slow walkers; 11%). The most likely to be non-responders were cluster 4 (older men, GOLD III-IV, dyspneic, very slow walkers, oxygen-dependent; 26%). CONCLUSION: Our data identified homogeneous patient clusters representing clinically relevant subgroups of COPD patients regarding their 6MWD response to PR. Clusters having the largest probability of being non-responders were older, more severe, with severe oxygen desaturation and dyspnea, limited 6MWD and requiring long-term oxygen therapy. These results may improve patient phenotyping in clinical practice and allow individualization of therapy.

Predictors of changes in 6-min walking distance following pulmonary rehabilitation in COPD patients: a retrospective cohort analysis.

BACKGROUND: Pulmonary rehabilitation (PR) is fundamental in chronic obstructive pulmonary disease (COPD) management but not all patients may show functional benefits from PR. AIM: The aim of this study was to identify predictors of non-response in functional capacity to PR. DESIGN: Observational study. SETTING: Inpatient pulmonary rehabilitation center. POPULATION: COPD patients. METHODS: This single center study is a retrospective analysis of data in COPD patients admitted to a PR center between January 2012 and December 2017. Post-PR change in 6-min walking distance (6MWD) was used to determine the functional response to PR. Patients characteristics and pre-PR 6-min walking test responses were analyzed to determine factors associated with post-PR changes in 6MWD. RESULTS: Data from 835 patients were analyzed as well as a subgroup of 190 patients with additional variables available. Eighty percent of the patients showed clinically significant 6MWD improvement post-PR. The predictors of 6MWD response to PR were age, pre-PR 6MWD, pre-PR end-of-test dyspnea and long-term oxygen therapy. Older patients, longer pre-PR 6MWD, higher pre-PR end-of-test dyspnea score and the use of oxygen supplementation were associated with lesser post-PR 6MWD improvement. CONCLUSIONS: This study identified four important clinical variables predicting a lack of 6MWD response to PR. CLINICAL REHABILITATION IMPACT: Patients with such clinical characteristics may require specific PR modalities to improve their functional benefit.

Trajectories of COPD patients' response to repeated pulmonary rehabilitation programs.

BACKGROUND AND OBJECTIVE: Pulmonary rehabilitation (PR) is essential in the management of chronic obstructive pulmonary disease (COPD), but the long-term effects and the outcomes of repeated programs especially in non-responders remain to be clarified. The aim of this study is to evaluate the long-term effect of PR 12 months after and the effect of repeated PR depending on the patient's response to the first PR. METHODS: This is a single center retrospective analysis of COPD patients admitted to two or three PR programs between January 2012 and December 2017, using the 6-min walking distance (6MWD) to determine the functional response to PR. RESULTS: One hundred ninety patients completed PR twice and 62 completed PR three times with 10-14 months delay between programs. The effect of the first PR program (PR1) on 6MWD was mostly lost after one year. The 6MWD change after the second PR program (PR2) was smaller than after PR1 (+65 ± 30 m post-PR1, +44 ± 20 m post-PR2; p = 0.001). Out of the 149 responders post-PR1, 44 (30%) became non-responders post-PR2. Out of the 41 non-responders post-PR1, 23 (56%) became responders post-PR2. Patients with long term oxygen therapy and severe exercise dyspnea were most likely to remain non-responders to repeated PR. CONCLUSION: This study showed that most of the 6MWD improvement following PR disappears over 12 months and emphasized the clinical relevance of repeating PR including for non-responders to initial PR. However, some patients did not respond systematically to PR and may require specific PR modalities to improve their functional status.

The effect of heated humidified nasal high flow oxygen supply on exercise tolerance in patients with interstitial lung disease: A pilot study.

BACKGROUND AND OBJECTIVES: Patients with interstitial lung disease (ILD) experience early symptoms of dyspnoea and leg fatigue during exercise together with severe and rapid oxygen desaturation. Heated and humidified nasal high flow oxygen (NHF) has been proven to enhance exercise endurance and physiological parameters in COPD patients. This study aims to evaluate the effect of NHF on exercise tolerance in ILD patients. METHODS: Twenty-five patients (10 female) with severe ILD performed three constant-load (70% maximal workload) cycling tests to exhaustion under different breathing conditions: room air, oxygen supplementation (4 L min-1 O2) and NHF (inspiratory O2 fraction 0.5, 30-50 L min-1, heated 34 °C and humidified). RESULTS: Endurance time was significantly longer with NHF (618 ± 297 s) compared to O2 (369 ± 217 s, p < 0.001) and room air (171 ± 76 s, p < 0.001). Kinetics of oxygen desaturation, chronotropic response, dyspnoea and leg fatigue sensations were delayed with NHF. At exhaustion with NHF, compared to the two other conditions, oxygen desaturation was less severe while heart rate, dyspnoea and leg fatigue were similar. CONCLUSION: NHF significantly improved endurance time, physiological parameters and sensations during exercise in severe ILD patients. NHF may be useful to improve functional capacities and facilitate pulmonary rehabilitation in ILD.

Minimal clinically important difference of 3-minute chair rise test and the DIRECT questionnaire after pulmonary rehabilitation in COPD patients.

BACKGROUND: The 3-minute chair rise test (3-minute CRT) and the Disability Related to COPD Tool (DIRECT) are two reproducible and valid short tests that can assess the benefit of pulmonary rehabilitation (PR) in terms of functional capacity and dyspnea in everyday activities. METHODS: We determined the minimal clinically important difference (MCID) of the DIRECT questionnaire and 3-minute CRT using distribution methods and anchor encroaches with a panel of eight standard tests in a cohort of 116 COPD patients who completed a PR program in real-life settings. RESULTS: The estimated MCID for the 3-minute CRT and DIRECT scores was five repetitions and two units, respectively, using separate and combined independent anchors. The all-patient (body mass index-obstruction-dyspnea-exercise [BODE] scores 0-7), BODE 0-2 (n=42), and BODE 3-4 (n=50) groups showed improvements greater than the MCID in most tests and questionnaires used. In contrast, the BODE 5-7 group (n=24) showed improvements greater than MCID in only the 3-minute CRT, 6-minute walk test, endurance exercise test, and DIRECT questionnaire. DISCUSSION AND CONCLUSION: This study demonstrates that the short and simple DIRECT questionnaire and 3-minute CRT are responsive to capture the beneficial effects of a PR program in COPD patients, including those with severe disease. TRIAL REGISTRATION NUMBER: NCT03286660.

CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) has been associated with hypertension, which is one of the intermediary mechanisms leading to increased cardiovascular morbidity. This study aimed at evaluating the effects of a combination of continuous positive airway pressure (CPAP) and telemedicine support on blood pressure (BP) reduction in high cardiovascular risk OSA patients. DESIGN: A multi-center randomized controlled trial that compared standard CPAP care and CPAP care and a telemedicine intervention. SETTING: Sleep clinics in France. PATIENTS OR PARTICIPANTS: 107 adult (18-65 years old) OSA patients (AHI > 15 events/h) with a high cardiovascular risk (cardiovascular SCORE > 5% or secondary prevention). INTERVENTIONS: Patients were randomized to either standard care CPAP (n = 53) or CPAP and telemedicine (n = 54). Patients assigned to telemedicine were equipped with a smartphone for uploading BP measurements, CPAP adherence, sleepiness, and quality of life data; in return, they received pictograms containing health-related messages. MEASUREMENTS: The main outcome was home self-measured BP and secondary outcomes were cardiovascular risk evolution, objective physical activity, CPAP adherence, sleepiness and quality of life. RESULTS: Self-measured BP did not improve in either group (telemedicine or standard care). Patients in primary prevention showed greater BP reduction with CPAP treatment than those in secondary prevention. CONCLUSIONS: CPAP treatment supported by telemedicine alone did not improve blood pressure and cardiovascular risk in high cardiovascular risk OSA patients. This study emphasizes the need for diet and physical activity training programs in addition to CPAP when aiming at decreasing cardiometabolic risk factors in these patients. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT01226641.

Low physical activity is a determinant for elevated blood pressure in high cardiovascular risk obstructive sleep apnea.

INTRODUCTION: Obstructive sleep apnea (OSA) is associated with cardiovascular morbidity, including hypertension. Beyond the severity of nocturnal hypoxia, other factors such as metabolic abnormalities but also sedentary behaviors and insufficient physical activity may contribute to elevated blood pressure (BP). To clarify the respective role of these factors as determinants of BP in OSA patients, we examined the relationship between BP and anthropometrics, severity of sleep apnea, and objectively measured physical activity and sedentary behaviors. METHODS: Ninety-five adults presenting with OSA (apnea-hypopnea index > 10 events/h) and high cardiovascular risk (63.3 ± 8.8 y; body mass index: 29.9 ± 4.9 kg/m(2); apnea-hypopnea index: 41.3 ± 17.5/h; cardiovascular risk score: 13.5 ± 3.7%) were included. Physical activity and sedentary behaviors were objectively assessed by actigraphy, and self-measured home BP monitoring was measured. Logistic regression models adjusted for sex, age, and body mass index were built to identify the predictors of self-measured morning and evening BP. RESULTS: Physical activity was significantly related to obesity but not to the severity of sleep apnea or sleepiness. Sedentary behaviors were associated with self-measured morning and evening systolic BP (r = 0.32, P = .002; r = 0.29, P = .004). Steps per day were inversely associated with evening BP (r = -0.27, P = .01). Univariate analysis identified steps/d and time spent in vigorous physical activity as determinants for evening self-measured BP. In multivariate analysis, only steps/d were identified as a significant determinant of evening BP. CONCLUSIONS: Physical activity is the major determinant for evening BP in adults with OSA presenting high cardiovascular risk. Our results emphasize the need for lifestyle counseling programs in combination with CPAP to encourage regular physical activity in OSA subjects to obtain better BP control. (ClinicalTrials.gov registration NCT01226641.)

Auto bi-level with pressure relief during exhalation as a rescue therapy for optimally treated obstructive sleep apnoea patients with poor compliance to continuous positive airways pressure therapy--a pilot study.

BACKGROUND: Continuous positive airways pressure (CPAP) is the accepted therapy for obstructive sleep apnoea (OSA), but compliance is variable. We hypothesised that an auto bi-level device with pressure relief during exhalation (auto bi-level) would treat OSA as well as CPAP and that transitioning non-compliant CPAP patients without modifiable causes of poor compliance to this device would improve compliance and clinical outcomes. MATERIALS AND METHODS: OSA patient's on positive airways pressure therapy with compliance below 4 h of use on ≥70% of nights over the past 3 months despite having no modifiable causes of poor compliance were transitioned onto an auto bi-level device for 10 weeks. Patients completed an Epworth sleepiness scale and Functional Outcomes of Sleep Questionnaire (FOSQ) at 15 days and 10 weeks and had their compliance and therapy data downloaded. Additionally, patients underwent polysomnography on their auto bi-level device at week 10. RESULTS: Thirty-five patients were included. The apnoea-hypopnoea index, arousal index, sleep efficiency, total sleep time and sleep stage distribution were similar at baseline and week 10. Compliance, excessive daytime sleepiness and several FOSQ domains improved significantly at day 15 and week 10. Patients requiring an effective pressure ≥10 cmH(2)0 during the lead-in period on CPAP experienced greater significant improvements compliance than those requiring an effective pressure <10 cmH(2)0. CONCLUSIONS: Auto bi-level with pressure relief during exhalation treats OSA as effectively as CPAP without inducing additional arousals. Transitioning non-compliant CPAP patients without modifiable causes of poor compliance from their CPAP to this new device improves compliance and clinical outcomes over a 10-week period.